What side effects are associated with this type of intervention?

Common treatments for gastrointestinal cancer, such as capecitabine, are associated with several side effects. Capecitabine, an oral chemotherapy, can cause hand-foot syndrome, diarrhea, nausea, vomiting, stomatitis, fatigue, and partial alopecia. Severe cases of hand-foot syndrome and diarrhea are particularly notable. These side effects are similar to those of its intravenous counterpart, fluorouracil. Monitoring and managing these side effects are crucial for maintaining treatment efficacy and patient safety.

What prior FDA approvals exist?

The FDA has approved several treatments for gastrointestinal cancers, including oral chemotherapies such as capecitabine and fluoropyrimidines like fluorouracil (5-FU). Capecitabine, an oral prodrug of 5-FU, is used for colorectal and gastric cancers, often in combination with other agents like oxaliplatin (as in the CAPOX regimen) or as monotherapy. Fluorouracil, often combined with leucovorin, is a cornerstone in the treatment of colorectal cancer. Targeted therapies, such as bevacizumab (an anti-VEGF monoclonal antibody), have also been approved for use in combination with chemotherapy for metastatic colorectal cancer. These treatments align with the types of regimens being studied in trials focused on remote patient management and oral chemotherapy adherence.

What other types of research exist?

Promising alternatives to Remote Patient Management Systems for gastrointestinal cancer patients in 2024 include: 1) Advanced oral chemotherapy agents like S-1, which offer similar efficacy to intravenous therapies with better tolerance. 2) Combination therapies such as capecitabine with other oral or parenteral chemotherapies, which can enhance treatment effectiveness. 3) Telemedicine platforms that provide comprehensive care, including virtual consultations, remote monitoring, and digital adherence tools. 4) Personalized treatment strategies using biomarkers and genetic profiling to tailor therapies to individual patient needs.

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Behavioural Intervention

SMS Chatbot Support for Gastrointestinal Cancer

N/A

Recruiting

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Capecitabine ONLY

* Capecitabine concurrent with Radiation Therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial focuses on using capecitabine, an oral chemotherapy drug, for cancer patients who manage their treatment at home. The goal is to help these patients take their medication correctly and manage side effects better. Capecitabine works by stopping cancer cells from growing and spreading and is used in the treatment of various cancers, including advanced breast and colorectal cancer.

Who is the study for?

This trial is for patients with gastrointestinal cancers who are taking oral chemotherapy, specifically capecitabine alone or in combination with other treatments like oxaliplatin, temozolomide, radiation therapy, or mitomycin.

What is being tested?

'Penny' is a chatbot delivered via the Memora Platform designed to help these patients manage their medication schedules and side effects. The study aims to improve adherence to complex oral chemotherapy regimens and better handle toxicity by providing remote guidance and monitoring.

What are the potential side effects?

While 'Penny' itself doesn't cause side effects, it helps manage those from oral chemotherapies like capecitabine which can include digestive issues, fatigue, hand-foot syndrome (redness/pain/swelling of hands/feet), and blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Medication Compliance - Will assess accuracy of medication reminders to patients and patient adherence to prescribed medication dosing and schedule

Patient Engagement with the Penny chatbot

Patient Safety of the Patient - Penny Chatbot interactions with patients will be assessed for accuracy of medication directions and triaging of symptoms reported and number of incorrect interactions between Penny and Patients will be measured.

Secondary study objectives

Patient Satisfaction with the Penny chatbot interactions will be measured by the Promoter Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Penny, a SMS Text-based chatbot interventionExperimental Treatment1 Intervention

This is a single arm study. All recruited patients will be entered on the Penny SMS Text-based chatbot intervention.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gastrointestinal cancer, such as capecitabine, work by interfering with the DNA synthesis of cancer cells, thereby inhibiting their growth and proliferation. Capecitabine is an oral prodrug that is metabolized into 5-fluorouracil (5-FU) in the body, which then incorporates into the DNA and RNA of cancer cells, disrupting their function and leading to cell death. This mechanism is crucial for GI cancer patients as it allows for targeted therapy that can be administered at home, offering convenience and autonomy. However, the complexity of dosing and the potential for significant side effects necessitate careful monitoring and adherence to ensure efficacy and minimize toxicity. Understanding these mechanisms helps patients appreciate the importance of following their treatment regimen precisely and reporting any adverse effects promptly.

[Therapeutic adherence to oral cancer therapy and interdisciplinary management].